Model note · Cardiopulmonary Bypass
LivaNova Stockert Heater-Cooler System 3T
The Stockert 3T is a heater-cooler used with heart-lung machines. It circulates water through the oxygenator heat exchanger, the patient blanket and the cardioplegia heat exchanger to warm or cool the patient during bypass of 6 hours or less. It is not part of the blood path, but its water tank can grow nontuberculous mycobacteria (NTM) that can be carried by aerosol. Since 2017 LivaNova has issued deep cleaning services, validated disinfection instructions and a design upgrade. The 2020 Final Configuration (K191402) was tested to reduce transmission of aerosolised mycobacteria and draws tank emissions through a disposable aerosol collection set into the hospital vacuum.
The model
Maker, model and type.
- Maker
- LivaNova Deutschland GmbH (formerly Sorin Group Deutschland)
- Model
- Heater-Cooler System 3T (Final Configuration, with aerosol collection set)
- Device type
- Cardiopulmonary Bypass
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FDA classification and clearances | Cardiopulmonary bypass temperature controller, product code DWC; K052601 (2006), K191402 (25 February 2020, Final Configuration), K220635 (16 November 2022) | Source |
| Use | Circulates water through heat exchangers to warm or cool a patient during cardiopulmonary bypass lasting 6 hours or less | Source |
| Water circuits | Three circuits independent of the mains water supply: two patient circuits (blanket and oxygenator) fed from one tank, and one interchangeable cardioplegia circuit; circuits can be switched off separately to give more heating or cooling to the active ones | Source |
| Aerosol collection set | Disposable canister with a hydrophobic filter, connected between the 3T and the facility vacuum, drawing tank emissions under negative pressure; validated for a seven day use period | Source |
| Disinfection validation | Cleaning, disinfection and water preservation instructions validated to an intermediate level of disinfection and tested over 58 weeks | Source |
| REF numbers in recalls | 16-02-85 (120 V, 60 Hz) and 16-02-81 (240 V) | Source |
Recalls
Known FDA recalls.
- Z-1498-20202020-02-24
Validated cleaning and disinfection instructions issued to reduce the risk of NTM contamination.
FDA record - Z-0220-20202018-11-01
Disinfectant and water preservative could react and become ineffective; design upgrade to reduce aerosol emission (8,671 units).
FDA record - Z-1099-20192018-09-14
Six units tested positive for NTM after deep cleaning.
FDA record - Z-1901-20182018-04-20
Deep cleaning service made available in the US for units suspected of contamination or visible biofilm.
FDA record - Z-2771-20172017-06-30
Hydrogen peroxide could diffuse across certain oxygenator heat exchanger fibres.
FDA record
Safety
Safety warnings from the record.
- NTM in the tank water can be spread as aerosol; the Final Configuration changes were made and tested to reduce transmission of aerosolised mycobacteria. Source
- Hydrogen peroxide used in the water could diffuse through the fibres of certain oxygenators into the blood side above allowed limits (2017, 7,546 units). Source
Sources
Where this note comes from.
- FDA 510(k) K191402 summary, Heater-Cooler System 3T (Final Configuration)
- FDA 510(k) K220635 summary, Heater-Cooler System 3T
- openFDA device recall records for the 3T
- openFDA MAUDE problem counts for the 3T
- FDA, What is a heater-cooler device (with references on Mycobacterium chimaera transmission during cardiac surgery)
Not covered: The operating instructions were not read, so water volumes, temperature ranges, flow rates, the exact cleaning schedule and placement rules in theatre are not included. The FDA page lists references on Mycobacterium chimaera transmission from heater-cooler units; the clinical details (species, time to infection) should be added from those references before publishing.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Cardiopulmonary Bypass
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